search
Back to results

Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block

Primary Purpose

Acute Post-operative Pain, Nerve Block, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transversus abdominis plane block,
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Post-operative Pain focused on measuring quadratus lumborum block, transversus abdominis plane block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: ASA I-II-II patients who can adapt to the pain assessment scale will be included in the study. Exclusion Criteria: Patients under 18 years of age ASA IV patients patients with known allergy to analgesic drugs patients with any contraindications for the regional technique (patients with coagulation disorders, injection site infection, patients allergic to local anesthetics) patients with chronic analgesic use body mass patients with an index over 35 kg/m2

Sites / Locations

  • Mugla Sitki Kocman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

transversus abdominis plane block

quadratus lumborum plane block

Arm Description

The group that underwent bilateral transversus abdominis plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations

The group that underwent bilateral quadratus lumborum plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations

Outcomes

Primary Outcome Measures

To compare the two groups analgesic efficacy and opioid consumption within 24 hours postoperatively.
To compare the analgesic efficacy of transversus abdominis plane block and posterior approach quadratus lumborum block and opioid consumption within 24 hours postoperatively.

Secondary Outcome Measures

Duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block.
To determine whether there is a difference in terms of time until the first analgesic consumption, duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block.

Full Information

First Posted
January 24, 2022
Last Updated
October 4, 2023
Sponsor
Muğla Sıtkı Koçman University
search

1. Study Identification

Unique Protocol Identification Number
NCT06075498
Brief Title
Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block
Official Title
Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block After Open Radical Retropubic Prostatectomy Operation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
May 21, 2023 (Actual)
Study Completion Date
June 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prostate cancer is the second most common cancer and the fifth in cancer-related deaths. Open radical retropubic prostatectomy is the most common surgical treatment for localized prostate cancer. Open radical retropubic prostatectomy is associated with moderate pain. Severe pain in the postoperative period affects the length of hospital stay and morbidity. Multimodal analgesia applications for the management of postoperative pain are the main component of post-surgical recovery. Different analgesia modalities, including systemic opioid use and neuraxial analgesia, have been used for pain control after retropubic radical prostatectomy. Side effects of systemic and intrathecal opioids limit the potential benefits of these agents. Transversus abdominis plane block and quadratus lumborum block are blocks that can be used for postoperative analgesia in the abdominal and pelvic regions. There is no study in the literature comparing the efficacy of these two blocks for postoperative analgesia in open radical retropubic prostatectomy and their effects on narcotic consumption.
Detailed Description
Scope: Open radical retropubic prostatectomy operation is associated with moderate postoperative pain and affects hospital stay and morbidity. Nerve blocks used for postoperative analgesia are one of the components of multimodal analgesia. Transversus abdominis plane block (TAP) is a regional block (T7-L1) that blocks the sensory afferents of the anterior abdominal wall. It was first introduced as an anatomical landmark-based technique through Petit's lumbar triangle. Since then, the ultrasound-guided block technique has been defined and the effectiveness of this block in postoperative pain control in abdominal and gynecological surgeries has been demonstrated. The sensory distribution of TAP block includes the incisional pain of open prostatectomy. TAP block technique has been shown to be a safe and effective method of postoperative analgesia in various general surgery, urological surgery, plastic surgery and pediatric surgery operations. In addition, postoperative pain management after lower abdominal surgeries has been recommended as part of ERAS protocols. Quadratus lumborum block (QL) is used as one of the postoperative pain methods after abdominal surgery in all age groups. It has been reported that QL block with a posterior approach extends more easily into the thoracic paravertebral space or the thoracolumbar plane and can create analgesia from T 7 to L 1. The use of posterior QL (QL-2) blocks for postoperative analgesia after open retropubic prostatectomy operations has not been studied before and it is not known which one is superior. The primary aim of this study was to compare the analgesic efficacy of transversus abdominis plane block and posterior approach quadratus lumborum block and opioid consumption within 24 hours postoperatively. The secondary aim is to determine whether there is a difference in terms of time to first analgesic consumption, duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction, and complications related to the block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Post-operative Pain, Nerve Block, Prostate Cancer
Keywords
quadratus lumborum block, transversus abdominis plane block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
patients who underwent open retropubic prostatectomy
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Postoperative follow-up was evaluated by a research assistant blind to the procedure. groups 1 and 2 were presented to the Outcome Assessor.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
The group that underwent bilateral transversus abdominis plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations
Arm Title
quadratus lumborum plane block
Arm Type
Active Comparator
Arm Description
The group that underwent bilateral quadratus lumborum plane block with 0.375 mg 20 ml bupivacaine on each side after open retropubic prostatectomy operations
Intervention Type
Procedure
Intervention Name(s)
transversus abdominis plane block,
Other Intervention Name(s)
quadratus lumborum plane block
Intervention Description
2 different plan blocks; 1. transversus plane block 2. quadratus lumborum plane block
Primary Outcome Measure Information:
Title
To compare the two groups analgesic efficacy and opioid consumption within 24 hours postoperatively.
Description
To compare the analgesic efficacy of transversus abdominis plane block and posterior approach quadratus lumborum block and opioid consumption within 24 hours postoperatively.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block.
Description
To determine whether there is a difference in terms of time until the first analgesic consumption, duration of sensory block, opioid-related side effects (postoperative nausea and vomiting, itching, sedation), patient satisfaction and complications related to the block.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients will be included in the study, as there are patients who underwent prostate surgery.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II-II patients who can adapt to the pain assessment scale will be included in the study. Exclusion Criteria: Patients under 18 years of age ASA IV patients patients with known allergy to analgesic drugs patients with any contraindications for the regional technique (patients with coagulation disorders, injection site infection, patients allergic to local anesthetics) patients with chronic analgesic use body mass patients with an index over 35 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
basak altiparmak
Organizational Affiliation
Mugla Sitki Kocman University Department of Anesthesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ahmet pinarbasi
Organizational Affiliation
Mugla Sitki Kocman University Department of Anesthesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ilker akarken
Organizational Affiliation
Mugla sitki kocman department of urology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
bakiye ugur
Organizational Affiliation
Mugla Sitki Kocman Universty of Anaesthesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
eylem yasar
Organizational Affiliation
Mugla Sitkı Kocman Training and research hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mugla Sitki Kocman University
City
Mugla
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only the IPD (after the unidentification of the patients) will be available by correspondence author e-mail.

Learn more about this trial

Comparison of Analgesia Efficacy of Transversus Abdominis Plane Block and Posterior Approach Quadratus Lumborum Block

We'll reach out to this number within 24 hrs